Tuesday, June 16, 2015

Denial of IPR Petition Sends Roche/Mayo Patent Back to District Court to Face Invalidation Under 101

On June 11, 2015, the Patent Trial and Appeal Board (PTAB)
denied a petition for Inter Partes Review (IPR) filed by Cepheid against patent
owners Roche Molecular Systems and Mayo Foundation for Medical Education and
Research in connection with US patent number 5,643,723 (Case IPR2015-00255). The
’723 patent “is directed to methods based on the polymerase chain reaction
(PCR) for the detection of Mycobacterium tuberculosis (MTB) and concurrent
determination of its drug susceptibility, utilizing the appropriate
oligonucleotide primers.” Claim 1 is representative.

(a) subjecting DNA from the biological sample to polymerase
chain reaction using a plurality of primers under reaction conditions
sufficient to simplify a portion of a M. tuberculosis rpoB gone to produce an amplification
product, wherein the plurality of primers comprises at least one primer that
hybridizes under hybridizing conditions to the amplified portion of the gone at
a site comprising at least one position-specific M. tuberculosis signature
nucleotide selected, with reference to FIG. 3 (SEQ D NO:1), from the group
consisting :

a G at nucleotide position 2312,

a T at nucleotide position 2313,

an A at nucleotide position 2373,

a G at nucleotide position 2374,

an A at nucleotide position 2378,

a G at nucleotide position 2408,

a T at nucleotide position 2409,

an A at nucleotide position 2426,

a G at nucleotide position 2441,

an A at nucleotide position 2456, and

a T at nucleotide position 2465; and

(b) detecting the presence or absence of an amplification
product, wherein the presence of an amplification product is indicative of the
presence of M. tuberculosis in the biological sample and wherein the absence of
the amplification product is indicative of the absence of M. tuberculosis in
the biological sample.

The patent also includes product claims directed towards
primers for use in this diagnostic method.

The petition for IPR was prompted by a lawsuit that Roche
Molecular Systems filed on July 16, 2014, alleging that Cepheid’s
XpertMTB/RIFAssay infringes the patent (Roche Molecular System v. Cepheid, Docket
No. C-14-3228, N.D. Cal.). The district court stayed the litigation on
January 7, 2015, pending the outcome of the IPR. The magistrate judge that
entered the stay noted that the PTAB has invalidated at least one patent
claim in approximately 84% of its final written decisions, and that this “data
reflects a relatively high probability that at least some of the claims at
issue in this litigation will be selected for IPR and eventually canceled.
Accordingly, a stay has the potential to greatly simplify these Court proceedings,
weighing in favor of a stay.”

Now that the stay will presumably be lifted and the infringement litigation resumed,
the issue of patent eligibility will likely take center stage. IPR
is limited by statute to invalidation challenges based on prior art, i.e., for lack of novelty
or obviousness, and thus patent ineligibility under 101 cannot be raised
as a basis to invalidate claims in IPR. However, the patent claims at issue in this case clearly implicate
patent eligibility concerns.Cepheid has
already raised the issue of patent eligibility in the district court prior to
the stay, arguing that the patent “contains claims that are not patent-eligible
in light of the Supreme Court’s recent significant decision [in Myriad] that a naturally occurring DNA
segment is a product of nature and not patentable.”

While
Myriad calls into serious question the validity of the primer claims, it is
the Supreme Court’s decision in Mayo v.
Prometheus, and the Federal Circuit’s recent interpretation of Mayo in Ariosa, that will provide Cepheid with its strongest basis for
arguing that the method claims are patent ineligible. Thus, somewhat
ironically, there is a good change that one of Mayo’s own patents will be brought down
by the Mayo decision.

About Me

I am a law professor at the University of Missouri-Kansas City School of Law. My primary research interests lie at the intersection of biotechnology and intellectual property. This blog provides analysis and commentary on recent developments relevant to this area of the law.